Model Number UNIVERS REVERS GLENO 39 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that a revision was necessary after a distal protrusion of the long humeral shaft.The patient will be rehabilitated at a later date after a humeral bone grafting procedure.The base plate including screws have remained in the patient.No further information were provided.
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Manufacturer Narrative
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Complaint confirmed.X-ray provided shows the bone protrusion.The ar-9504m device was not returned for evaluation.And the picture provided did not show any abnormality.The cause of the event is undetermined.
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Search Alerts/Recalls
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